The intrinsic foot muscle research

JRCT ID: jRCT1020230007

Registered date:23/05/2023

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Healthy person
The intrinsic foot muscles contribute to preventing injury and stabilizing the foot.

• Date of first enrollment: 23/05/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Patients who visit orthopedic sports outpatient clinic (Fridays of the 2nd and 4th week) after April 2023 will be allocated to the study. As a method of allocation, patients who give consent in the 2nd week will be assigned to the toe rock-paper-scissors group, and patients who give consent in the 4th week will be assigned to the towel-gathering group.
Both groups will be asked to train everyday, and to record the number of training sessions per week by filling out a Google form once a week. Training will continue for 6 months. Training will be supervised by a physician or physical therapist in the outpatient clinic or rehabilitation room.
The evaluation method will be performed as described in the primary and secondary endpoints. When measuring the cross-sectional area of intrinsic and extrinsic foot muscles in ultrasonography, the primary endpoint, a diagnostic ultrasound device as described in 2(2) will be used.
The primary and secondary endpoints (1)-(3) will be evaluated before and at 1, 3, and 6 months after intervention, and the secondary endpoints (4) and (5) will be performed before and at 6 months after intervention.

Outcome(s)

• Primary Outcome: Cross-sectional area of intrinsic and extrinsic foot muscles in ultrasonography

Secondary Outcome

(1) Star Excursion Balance Test (SEBT)
(2) Navicular index
(3) Score of the toe rock-paper-scissors
(4) One-leg standing test
(5) Electromyographic activity of intrinsic and extrinsic foot muscles

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

(1)Patients who visited the outpatient clinic of the Department of Orthopedics (Sports Medicine) at Tohoku University Hospital
(2) Patients who have given their written consent to participate in the research

Exclude criteria

(1) History of foot and ankle surgery (either left or right)
(2) Patients who can not walk alone
(3) undergoing medical treatment for foot and ankle
(4) Patients who did not give their written consent to participate in the research

Related Information

• Primary Sponsor: Aki Takashi
• Secondary Sponsor: Nagamoto Hideaki